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Cell Transplant. 2016 Nov;25(11):1925-1943. doi: 10.3727/096368916X691411.

Phase I-II Clinical Trial Assessing Safety and Efficacy of Umbilical Cord Blood Mononuclear Cell Transplant Therapy of Chronic Complete Spinal Cord Injury.

Author information

1
Kunming General Hospital of Chengdu Military Command, Yunnan, P.R. China.
2
Kunming Tongren Hospital, Yunnan, P.R. China.
3
Prince of Wales Hospital, Division of Neurosurgery, Department of Surgery, Chinese University of Hong Kong, Shatin, Hong Kong, SAR, P.R. China.
4
Queen Mary Hospital, University of Hong Kong, Hong Kong, SAR, P.R. China.
5
Department of Ophthalmology and State Key Laboratory of Brain and Cognitive Science, The University of Hong Kong, SAR, P.R. China.
6
GHM Institute of CNS Regeneration, and Medical Key Laboratory of Brain Function and Diseases, Jinan University, Guangzhou, P.R. China.
7
China Spinal Cord Injury Network, Hong Kong Science Technology Park, Hong Kong, SAR, P.R. China.
8
Vista Biological Laboratory, Carlsbad, CA, USA.
9
W. M. Keck Center for Collaborative Neuroscience, Rutgers University, Piscataway, NJ, USA.

Abstract

Umbilical cord blood-derived mononuclear cell (UCB-MNC) transplants improve recovery in animal spinal cord injury (SCI) models. We transplanted UCB-MNCs into 28 patients with chronic complete SCI in Hong Kong (HK) and Kunming (KM). Stemcyte Inc. donated UCB-MNCs isolated from human leukocyte antigen (HLA ≥4:6)-matched UCB units. In HK, four patients received four 4-μl injections (1.6 million cells) into dorsal entry zones above and below the injury site, and another four received 8-μl injections (3.2 million cells). The eight patients were an average of 13 years after C5-T10 SCI. Magnetic resonance diffusion tensor imaging of five patients showed white matter gaps at the injury site before treatment. Two patients had fiber bundles growing across the injury site by 12 months, and the rest had narrower white matter gaps. Motor, walking index of SCI (WISCI), and spinal cord independence measure (SCIM) scores did not change. In KM, five groups of four patients received four 4-μl (1.6 million cells), 8-μl (3.2 million cells), 16-μl injections (6.4 million cells), 6.4 million cells plus 30 mg/kg methylprednisolone (MP), or 6.4 million cells plus MP and a 6-week course of oral lithium carbonate (750 mg/day). KM patients averaged 7 years after C3-T11 SCI and received 3-6 months of intensive locomotor training. Before surgery, only two patients walked 10 m with assistance and did not need assistance for bladder or bowel management before surgery. The rest could not walk or do their bladder and bowel management without assistance. At about a year (41-87 weeks), WISCI and SCIM scores improved: 15/20 patients walked 10 m ( p = 0.001) and 12/20 did not need assistance for bladder management ( p = 0.001) or bowel management ( p = 0.002). Five patients converted from complete to incomplete (two sensory, three motor; p = 0.038) SCI. We conclude that UCB-MNC transplants and locomotor training improved WISCI and SCIM scores. We propose further clinical trials.

KEYWORDS:

Central pattern generator; Lithium; Mononuclear cells; Spinal cord injury (SCI); Umbilical cord blood

PMID:
27075659
DOI:
10.3727/096368916X691411
[Indexed for MEDLINE]

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